Biosimilars Policy

Arthritis Consumer Experts (ACE) has been learning about biosimilars since 2009 and has become a national thought leader, conducting biosimilar workshops and sharing education with multi-stakeholder groups across Canada. The ACE biosimilars dialogue across Canada has included patients, healthcare professionals and policy decision makers in government and private health insurance.

Current policy decisions on biosimilars

What is ACE’s views on biosimilars policies in Canada?

As biosimilars research is published in peer reviewed medical journals and policies regulating them evolve, so do ACE’s organizational views. As always, ACE will follow the evidence.

ACE's mandate is to continue to provide the latest research-based education and information on biosimilars to its members, subscribers and the public, and our guiding principle has been, and continues to be, to follow the scientific evidence in our therapeutic area. Based on peer reviewed, well-designed research studies and current meta-analysis, our organization’s views are:

  • Treatment of patients living with inflammatory arthritis should ask for and expect the best care possible through shared decision-making between themselves, their rheumatologist and other healthcare providers;
  • Biosimilars may have advantages over their originators due to improvements in manufacturing processes, delivery devices, among others;
  • This new class of biologics is delivering significant drug plan savings without compromising safety and efficacy in thousands of patients in many European countries;
  • The evidence acquired over 10 years of clinical experience shows that biosimilars approved through European Medicines Agency can be used as safely and effectively in all their approved indications as other biological medicines;
  • Policy development related to biosimilars to treat inflammatory arthritis should include unbiased and credible patient and rheumatologist participation who fully disclose their sources of funding from the manufacturers of the drug products affected by the policy;
  • Patients should be fully informed about policy decisions that transition them to a biosimilar; patients should be able to assess treatment (or no treatment) risk against benefit, and have tools to enable them to discuss the pros and cons of all treatments with their healthcare team;
  • Policy transition is appropriate if the prescribing physician and their patient have the education and information tools they need to support the patient in all aspects of accessing their biosimilar, from “care coach” to help with formulary or private insurance paperwork, to infusion clinic and pharmacy orientation, and adherence;
  • Government should reinvest policy transition savings in a timely manner into innovative medicines on formularies for unmet patient needs, list biologics and tsDMARDs with revised/relaxed reimbursement criteria to make access more efficient, and implement other important aspects of inflammatory arthritis models of care, such as instituting rheumatology nursing billing codes;
  • Policy transitioned patients should be monitored as part of their routine care;
  • Outcomes data should be collected on patients in whom multiple transitions are made between biosimilars and originators.

Understanding biosimilar terminology: transitioning, interchangeability, and substitution

In 2016 and the first half of 2017, as discussion around biosimilars in Canada has intensified, ACE has identified the need for clarifying issues and concerns related to policy terminology. From our discussions with stakeholders and our attendance at public and private sector biosimilars forums and workshops, ACE has observed that “transition” or “switch,” “therapeutic substitution” and “interchangeability” were all being used to describe transitioning a patient from an originator to its relevant biosimilar. At the same time, Health Canada, the US Federal Drug Administration and the European Medicines Agency have all issued further guidance on regulating biosimiliars in their countries. In all three environments, policy makers are increasingly aligning their policies, based on scientific evidence on safety and efficacy, on physician-led transitioning.

Comparing Biosimilars Policies: Canada, U.S. and the European Union

Starting with Canada, ACE provides you the following summary of biosimilars policy positions in Canada, the U.S. and the European Union as they continue to evolve.

Current Canadian Biosimilars Policies

While Canada has lagged behind Europe in terms of approving biosimilars, where regulators have approved 20 biosimilars between 2006 and 2016, Health Canada is beginning to narrow the gap.  Since 2015, it has approved three biosimilars:

Omnitrope (somatropin); Inflectra (infliximab); and Brenzys (etanercept).

In December 2016, Health Canada released its revised Guidance Document on the approval pathway for biosimilars - Information and Submission Requirements for Biosimilar Biologic Drugs - based on experience gained as well as international developments in the regulation of biosimilars. As anticipated, one of the major changes is in the name: Health Canada has retired the "subsequent-entry biologics" term and now uses “biosimilars.”

Health Canada has also revised its fact sheet on biosimilars. In line with recent changes to the Guidance Document, the Fact Sheet has been substantially rewritten and contains an overview and description of the regulatory framework for biosimilars. The Fact Sheet also includes a new section on drug and patient access and further defines transitioning or switching and interchangeability.

Health Canada on transitioning

In terms of “transitioning” or “switching,” Health Canada recommends those decisions should be made by the physician and their patient:

“Switching generally refers to a one-time change from a reference biologic drug to a biosimilar. Health Canada recommends that a decision to switch a patient being treated with a reference biologic drug (innovator product) to a biosimilar should be made by the treating physician in consultation with the patient and taking into account available clinical evidence and any policies of the relevant jurisdiction. For questions related to changing from one biologic drug to another, patients should speak to their doctor.”

In 2017, there is convergence across Canadian provinces and territories that patients newly prescribed infliximab for rheumatoid arthritis, psoriatic arthritis, ankylosing arthritis and plaque psoriasis are reimbursed for the biosimilar infliximab (Inflectra) in place of the originator biologic - infliximab (Remicade).

Health Canada on interchangeability

For both drug manufacturers and health systems, interchangeability is seen as a major benefit to biosimilar development, as it allows a pharmacist to automatically substitute a biosimilar for its originator biologic when it has been deemed interchangeable by a Provincial or Territorial regulatory body. For instance, this is a common practice for drugs that are off patent and have been deemed interchangeable with their generic equivalent. Unlike generic drugs however, biosimilars are not chemically identical to their originator biologics, which is the reason why prescribers and pharmacists are unable to automatically substitute one for the other. To achieve interchangeable status, drug manufacturers will have to conduct trials aimed at determining whether transitioning from an originator biologic to a biosimilar poses any risk to the patient.

In the Fact Sheet, Health Canada provides its current position on designating a biosimilar as interchangeable:

“Health Canada's authorization of a biosimilar is not a declaration of equivalence to the reference biologic drug. There are varying definitions of interchangeability. In Canada, the term often refers to the ability for a patient to be changed from one drug to another equivalent drug by a pharmacist, without the intervention of the doctor who wrote the prescription. In Canada, the authority to declare two products interchangeable rests with each province and territory according to its own rules and regulations.”

In other words, Health Canada's authorization of a biosimilar is independent of provincial, territorial, or private drug plan decisions regarding its formulary listing and reimbursement or any decision as to interchangeability between these drugs. According to the new guidance from Health Canada, interchangeability decisions rest with provincial or territorial governments.

International Biosimilars Policy Perspectives

United States

In January 2017, the US Food and Drug Administration (FDA) released its draft guidance, which was initially expected to be published before the end of 2015, on biosimilar interchangeability with its originator biologic. This new regulatory framework sets the bar high for manufacturers of biosimilars. In the US, only four biosimilars have been approved to-date, none of which are considered to be interchangeable with their originator biologic.

According to the FDA, biosimilars will need to demonstrate the same clinical results (e.g. safety, purity, potency) as originator biologics for all approved indications, in order to be considered interchangeable. According to the FDA guidance, post-marketing studies for already-approved biologics will not be sufficient to support an application for interchangeability. The FDA guidance recommends that sponsors looking to get a biosimilar approved as interchangeable with its originator biologic conduct one or more switching studies to show that patients can alternate between a biosimilar and its originator biologic two or more times safely and without diminished efficacy.

ACR Response

The American College of Rheumatology (ACR) responded to the FDA guidance stating that the document addresses many of the safety and efficacy concerns physicians and patients have raised.

“The ACR is pleased to see the FDA issue draft guidance on biosimilar interchangeability,” expressed Dr. Angus Worthing, MD, FACP, chair of the ACR’s Government Affairs Committee. “This guidance brings us one step closer to the shared goal of lowering prices in the biologics marketplace. While the ACR is still reviewing the document and will provide detailed comments to the FDA in the coming weeks, our initial reaction is that the draft guidance strikes a good balance between ensuring safety and efficacy while also getting biosimilar products to market as efficiently as possible.”

“We also applaud the FDA for suggesting clinical studies which switch back and forth, not just one-way from the reference drug to the biosimilar. The use of at least two exposure periods to each drug will mimic to some extent what our patients are likely to experience with changing formularies in a multi-payer, multi-state, ever-changing market."

European Union

While relatively new to Canada, biosimilars have been approved for use in the European Union (EU) for a decade and for use in arthritis since 2013.

Currently, in the EU, the definitions of transitioning-switching, interchangeability and substitution are as follows:

Transitioning-Switching – decision by treating physician to exchange one medicine for another medicine with the same therapeutic intent

Interchangeability – the medical practice of changing one medicine for another that is expected to achieve the same clinical effect in a given clinical setting and in any patient on the initiative, or with the agreement of the prescriber

Substitution – practice of dispensing one medicine instead of another equivalent and interchangeable medicine at the pharmacy level with consulting the prescriber

In the EU, like in Canada, the ruling regulatory body (European Medicines Agency comparable to Health Canada) leaves the decision on a policy framework guiding the use of biosimilars to individual member countries (comparable to provincial and territorial policy decision making in Canada).

EU member countries generally agree to the fact that EU authorized biosimilars are considered alternative therapeutic options to their respective originator biologics, under the supervision of a clinical decision maker. The majority of countries, including England, Norway, Denmark, Germany, Netherlands, Belgium, France, and Portugal support physician led switching or transitioning for biosimilars. As of March 2017, there is also convergence across EU countries that biologics should not be substituted at the pharmacy level with the involvement of the clinical decision maker.

EU Associations and Patient Group Organization Response

Here is a brief summary of positioning statements by leading EU Medical Associations and Patient Groups:

European League Against Rheumatism (EULAR) - Biosimilars – 2015 What do patients need to consider?

  • National arthritis patient group organizations across Europe work together via the EULAR Standing Committee of PARE. Each EU member country is represented with one delegate in the committee.

  • The PARE committee issued a position paper on biosimialrs in 2015 where they stated many patients consider that leaving open the possibility of switching or transitioning, interchangeability and substitution would introduce unacceptable uncertainties into that decision-making process.

European Crohn’s and Colitis Organisation (ECCO) – 2016 ECCO position statement: the use of biosimilar medicines in the treatment of inflammatory bowel disease (IBD)

  • Switching* from the originator to a biosimilar in patients with IBD is acceptable

  • Clinical studies of equivalence in the most sensitive indication can provide the basis for extrapolation. Therefore data for the usage of biosimilars in IBD can be extrapolated from another sensitive indication.

  • When a biosimilar product is registered in the EU, it is considered to be as efficacious as the reference product when used in accordance with the information provided in the Summary of Product Characteristics.

  • Studies of switching can provide valuable evidence for safety and efficacy. Scientific and clinical evidence is lacking regarding reverse switching, multiple switching, and cross-switching among biosimilars in IBD patients.

  • Switching from originator to a biosimilar should be performed following appropriate discussion between physicians, nurses, pharmacists, and patients, and according to national recommendation. The IBD nurse can play a key role in communicating the importance and equivalence of biosimilar therapy.

*Please note the European Crohn's and Colitis Organisation uses the term "switching". ACE uses the term "transitioning".

European Society for Medical Oncology (ESMO) – 2017 Biosimilars: a position paper of the European Society for Medical Oncology, with particular reference to oncology prescribers

Interchangeability and switching should only be permitted if:

  • the physician is well-informed about the products;
  • the patient is fully briefed by the physician; and
  • a nurse is closely monitoring the changes and tracking any adverse events.
Policy framework and reimbursement access in Canada

Provincial formularies and private health insurers have begun providing reimbursement for the first biosimilar approved in Canada for the treatment of inflammatory forms of arthritis. Both provincial and private payers are considering biosimilars as a key element in their mandates to list cost-effective medication treatment that is clinically meaningful to patients and contributes to long-term cost reductions and drug plan sustainability.

Through the pan-Canadian Pharmaceutical Alliance (pCPA), provincial and territorial public drug plans negotiated a significantly lower transparent list price for Infliximab (Inflectra); according to the pCPA this will enable savings for both public and private payers that can be reinvested into other treatments or therapies. In April 2016, the pCPA released its First Principles for Subsequent Entry Biologics to guide negotiations and inform expectations of biosimilar manufacturers, as the pCPA works towards establishment of a biosimilars policy framework.

Determining the value to patients and the health care system
Tracking the efficacy, safety and value to patients and the health care system of both originator biologics and their biosimilars is important. Patients and their physicians rely on this "real world data" when they are making treatment decisions.

As biosimilars research data continues to be published and policies regulating them evolve, ACE is meeting with public formulary and private payer decision makers to provide its membership’s views on the placement of biosimilars in inflammatory arthritis therapy.

ACE is advocating to provincial governments to reinvest drug plan savings from biosimilars listings back to drug plan budgets by broadening formularies to include new medications addressing unmet patient needs. 

The first biosimilars in Canada

In 2015, the first biosimilar in Canada approved for inflammatory arthritis was infliximab (Inflectra®). It was launched to treat severe rheumatoid arthritis (RA), ankylosing spondylitis (AS), and psoriatic arthritis (PsA). In 2016, infliximab (Inflectra®) is being added to many provincial drug plans and private health insurance plans for the treatment of these diseases.

Infliximab (Inflectra®) is a biosimilar version of infliximab based upon the originator biologic infliximab (Remicade®). It was issued a Notice of Compliance (or “approved”) by Health Canada and recommended for listing on provincial formularies by the national Common Drug Review.

For information on Health Canada’s decision, please see the Summary Basis of Decision for infliximab (Inflectra®) available at:

https://health-products.canada.ca/noc-ac/info.do?lang=en&no=18169

Additional information may be found in the Inflectra® Product Monograph, approved by Health Canada and available here: 

https://pdf.hres.ca/dpd_pm/00035250.PDF

For Common Drug Review’s review and recommendation, please see: https://www.cadth.ca/sites/default/files/cdr/complete/cdr_complete_SE038...

The second biosimilar in Canada approved for inflammatory arthritis is etanercept (Brenzys®). It is a biosimilar version of etanercept based upon the reference product etanercept (Enbrel®). It was issued a Notice of Compliance by Health Canada on August 31, 2016 for the treatment of patients with rheumatoid arthritis and ankylosing spondylitis.

For information on Health Canada's decision, please see the Summary of Basis of Decision for etanercept (Brenzys®) availble at: https://health-products.canada.ca/noc-ac/info.do?lang=en&no=18480

Additional information may be found in the Brenzys® Product Monograph, approved by Health Canada and available here:

https://pdf.hres.ca/dpd_pm/00036407.PDF

For Common Drug Review's review and recommendation, please see: https://www.cadth.ca/sites/default/files/cdr/complete/SE0485_complete_Br...

The third biosimilar in Canada for inflammatory arthritis is etanercept (Erelzi®). It is a biosimilar version of etanercept based upon the reference product etanercept (Enbrel®). It was issued a Notice of Compliance by Health Canada on April 5, 2017 for the treatment of patients with rheumatoid arthritis, ankylosing spondylitis and juvenile idiopathic arthritis. 

For information on Health Canada's decision, please see the Summary Basis of Decision for etanercept (Erelzi®) available at: 

https://health-products.canada.ca/noc-ac/info.do?lang=en&no=19131

Additional information may be found in the Erelzi® Product Monograph, approved by Health Canada and available here: 

https://pdf.hres.ca/dpd_pm/00038823.PDF

For Common Drug Review's review and recommendation, please see: 

https://www.cadth.ca/sites/default/files/cdr/complete/SE0513_complete_Er...

Biosimilars Policy FAQs

Are patients taking infliximab (Remicade) or etanercept (Enbrel) and currently reimbursed by a provincial formulary or private drug plan required to transition to a biosimilar in place of the originator biologic?

Health Canada recommends that physicians make well-informed choices when considering interchanging therapies. Currently, provincial and private drug plans are not mandating policy transition between a patient’s current biologic to an approved biosimilar.

In terms of “transitioning” or “switching,” Health Canada recommends those decisions should be made by the physician and their patient:

“Switching generally refers to a one-time change from a reference biologic drug to a biosimilar. Health Canada recommends that a decision to switch a patient being treated with a reference biologic drug (innovator product) to a biosimilar should be made by the treating physician in consultation with the patient and taking into account available clinical evidence and any policies of the relevant jurisdiction. For questions related to changing from one biologic drug to another, patients should speak to their doctor.”

Click here to see Health Canada's Fact Sheet: Biosimilars: https://www.canada.ca/en/health-canada/services/drugs-health-products/biologics-radiopharmaceuticals-genetic-therapies/applications-submissions/guidance-documents/fact-sheet-biosimilars.html

Currently, provincial and private drug plans are not mandating policy transition between a patient’s current bioloigic to an approved biosimilar.

Except in Saskatchewan, there is convergence across Canadian provinces and territories that patients newly prescribed infliximab for rheumatoid arthritis, psoriatic arthritis, ankylosing arthritis and plaque psoriasis are reimbursed for the biosimilar in place of the originator biologic. There is convergence across Canadian provinces and territories that patients newly prescribed etanercept for rheumatoid arthritis and ankylosing spondylitis are reimbursed for the biosimilar in place of the originator biologic.

What diseases has infliximab (Inflectra) been approved for?

Infliximab (Inflectra®) was approved by Health Canada on June 14, 2016 for three new indications: Crohn's disease, Crohn's disease fistulae and ulcerative colitis.

What is the current funding status of infliximab (Inflectra) with Canadian private health insurers?

All private health insurers have listed Infliximab (Inflectra®).

Green Shield Canada and a number of other small insurers have criteria that mandates patients newly prescribed infliximab to receive infliximab (Inflectra®) in place of infliximab (Remicade®) for rheumatoid arthritis, psoriatic arthritis, and ankylosing arthritis.

In particular, Green Shield’s policy is to:

- Preferentially list biosimilars on its formularies

- Cover originator products in exceptional circumstances only

- Keep patients on originator biologics if they started treatment prior to its policy statement

As of May 1, 2016, Remicade (infliximab®) remains in first tier for all indications with the major insurers (e.g. Sun Life, Great West Life, Manulife).

What diseases has etanercept (Brenzys) been approved for?

Etanercept (Brenzys®) received a Health Canada Notice of Compliance on August 31, 2016 for the treatment of adult patients with moderate to severe rheumatoid arthritis and ankylosing spondylitis. Etanercept (Brenzys®) is a biosimilar to the originator biologic etanercept (Enbrel®) and the first subcutaneous anti-tumour necrosis factor (anti-TNF) biosimilar medication available in Canada. 

What diseases has etanercept (Erelzi) been approved for?

Etanercept (Erelzi®) received a Health Canada Notice of Compliance on April 5, 2017 for the treatment of adult patients with moderate to severe rheumatoid arthritis, ankylosing spondylitis and juvenile idiopathic arthritis and recommended for listing on provincial formularies by the national Common Drug Review. Etanercept (Erelzi®) is a biosimilar to the originator biologic etanercept (Enbrel®).

Have you been affected by new biosimilars policy?

Provincial formularies and private health insurers have begun providing reimbursement for the first biosimilar approved in Canada. Have you had experience gaining reimbursement for a biosimilar prescription with a provincial or private health insurance formulary?

Current funding status of infliximab (Inflectra) with provincial formularies

Infliximab (Inflectra) has been listed in a number of provinces across Canada. Here is a summary of the reimbursement criteria in those provinces.

Quebec

Effective February, 2015, RAMQ covers infliximab (Inflectra) and infliximab (Remicade) for the treatment of eligible rheumatology and dermatology indications – rheumatoid arthritis, psoriatic arthritis, ankylosing arthritis, plaque psoriasis – at a Maximum Allowable Cost, whereby physicians and patients may choose infliximab (Inflectra) or infliximab (Remicade) and the province obtains equal cost savings.

ACE is interested in hearing from patients about their experience with biosimilars in Quebec. Do you have biosimilar news to share?

British Columbia

Effective February 19, 2016, BC PharmaCare covers infliximab (Inflectra) for the treatment of eligible rheumatology and dermatology indications – rheumatoid arthritis, psoriatic arthritis, ankylosing arthritis, plaque psoriasis - according to existing Limited Coverage criteria. All Special Authority (SA) requests for coverage of infliximab for infliximab-naïve patients requiring the medication for rheumatoid arthritis, psoriatic arthritis, ankylosing arthritis and plaque psoriasis will be reimbursed for the infliximab (Inflectra) brand of infliximab only. Patients whose initial Special Authority was received before February 19, 2016, will be eligible for continued coverage of infliximab (Remicade).

Coverage of these drugs is subject to the rules of a patient's BC PharmaCare plan, including any annual deductible requirement. Retroactive coverage cannot be provided for prescriptions filled before Special Authority approval is in place. 

ACE is interested in hearing from BC patients about their experience with biosimilars. Do you have biosimilars news to share?

Ontario

Effective February 25 2016, infliximab (Inflectra) was added to the Ontario Drug Benefit (ODB) Formulary as a Limited Use (LU) benefit for the treatment of severe rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis. Only infliximab (Inflectra) for patients newly started on infliximab will be reimbursed by the province.

Patients who have an existing Exceptional Access Program (EAP) approval for infliximab (Remicade) can continue to receive infliximab (Remicade) for the duration of the EAP approval period. The ministry will also consider EAP renewal requests for infliximab (Remicade) for patients with existing EAP approvals.

The Limited Use (LU) criteria for infliximab (Inflectra) will apply to both new and existing patients with severe rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis.

Claims for infliximab (Inflectra) will be reimbursed under the ODB program when prescribed in accordance with the LU criteria and accompanied by a valid, fully completed prescription with the appropriate LU documentation (RFU code).

Limited Use drugs are those drugs recommended by Ontario’s external expert drug advisory committee as having value in specific circumstances, although they may not be considered for general listing in the public formulary. A LU listing allows a specialty physician, such as a rheumatologist or dermatologist, to write the prescription for infliximab (Inflectra) without having to fill out additional forms justifying the need for the prescription. A LU listing may save days or weeks of time that occurs in the Exceptional Access Program review process and allows the patient go directly to the pharmacy to have the prescription filled.

In March 2016, the Ontario Rheumatologist Association published this communication on their website, clarifying some special populations where patients newly prescribed infliximab (Remicade) will be eligible for funding under EAP in Ontario:

- Sub-populations: New starts for juvenile idiopathic arthritis (JIA) – all subtypes and both adult and pediatric Uveitis (non-infectious ocular inflammatory disease) who meet EAP criteria will continue to receive infliximab (Remicade).

- A patient who is on infliximab (Remicade) prior to February 25, 2016 and who meet EAP criteria will continue with infliximab (Remicade). At this time there is no mandatory switching.

- Clients age <65 previously on infliximab (Remicade) paid for by private insurance who turn 65 and meet EAP criteria are eligible to continue with infliximab (Remicade), without a mandatory switch to infliximab (Inflectra).

ACE is interested in hearing from patients about their experience with biosimilars in Ontario. Do you have biosimilar news to share?

Non-insured Health Benefits (NIHB)

As of March 9, 2016, the Non-Insured Health Benefits added infliximab (Inflectra) to the benefit list. It is approved for severely active rheumatoid arthritis on recommendation of a RA specialist.  All new infliximab patients for the above indication will be covered for the Inflectra brand only. 

ACE is interested in hearing from patients who receive benefits from the NIHB about their experience with biosimilars. Do you have biosimilar news to share?

Alberta

Effective April 1, 2016, all new Special Authorization requests for the treatment of ankylosing spondylitis, plaque psoriasis, psoriatic arthritis or rheumatoid arthritis for infliximab naive patients are assessed for coverage with infliximab (Inflectra). 

Infliximab (Remicade) will not be approved for patients, with ankylosing spondylitis, plaque psoriasis, psoriatic arthritis or rheumatoid arthritis, newly prescribed infliximab; however, coverage for infliximab (Remicade) will continue for patients who are currently well maintained on infliximab (Remicade) and are considered a 'responder' as defined in criteria. 

ACE is interested in hearing from Albertan patients about their experience with biosimilars. Do you have biosimilar news to share?

Manitoba

Effective April 18 2016, infliximab (Inflectra) was added to the Manitoba Drug Benefits and Interchangeability Formulary for the treatment of rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis.

All Special Authority (SA) requests for coverage of infliximab for infliximab-naïve patients requiring the drug for rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis will be approved for the infliximab (Inflectra) brand of infliximab only. Patients whose initial Special Authority was received before April 18, 2016, will be eligible for continued coverage of infliximab (Remicade).

ACE is interested in hearing from patients about their experience with biosimilars in Manitoba. Do you have biosimilar news to share?

Saskatchewan

Effective May 1, 2016, under the Non-Interchangeable Exception Drug Status Program (EDS), infliximab (Inflectra) is authorized for the treatment of ankylosing spondylitis, plaque psoriasis, psoriatic arthritis or rheumatoid arthritis. The listing allows patients, with ankylosing spondylitis, plaque psoriasis, psoriatic arthritis or rheumatoid arthritis, newly prescribed infliximab (“new starts”) to start with Infliximab (Inflectra) or infliximab (Remicade).

ACE is interested in hearing from Saskatchewan patients about their experience with biosimilars. Do you have biosimilar news to share?

New Brunswick

Effective June 1, 2016, under the New Brunswick Drug Plans Special Authorization Program, infliximab (Inflectra) will be approved for ankylosing spondylitis, plaque psoriasis, psoriatic arthritis, and rheumatoid arthritis.

Please note that all Special Authorization (SA) requests for reimbursement of infliximab for infliximab-naïve patients for ankylosing spondylitis (AS), psoriatic arthritis (PsA), and rheumatoid arthritis (RA) will be approved for the Inflectra brand of infliximab only. Patients who received SA approval for the Remicade brand of infliximab before June 1, 2016 will continue to have this brand covered. They will also be eligible for reimbursement of infliximab (Inflectra).

ACE is interested in hearing from patients about their experience with biosimilars in New Brunswick. Do you have biosimilar news to share?

Yukon

Effective May, 2016, infliximab (Inflectra) was approved to treat severely active rheumatoid arthritis, ankylosing spondylitis patients with a BASDAI score of 4, or psoriatic arthritis patients with moderate to severe disease who are refractory or intolerant to a 12-week trial of parenteral methotrexate and an adequate trial (at least 4 months) of at least one other DMARD.

All new infliximab patients for the above indications will be covered for Inflectra brand only.

ACE is interested in hearing from patients about their experience with biosimilars in Yukon. Do you have biosimilar news to share?

Newfoundland and Labrador

Effective June 1, 2016, the Newfoundland and Labrador Prescription Drug Program (NLPDP) added infliximab (Inflectra) to the benefit list for the treatment of severe rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis according to the Special Authorization criteria.

Inflectra will be the preferred infliximab option for all infliximab-naive patients prescribed an infliximab product for Ankylosing Spondylitis, Plaque Psoriasis, Psoriatic Arthritis or Rheumatoid Arthritis. Preferred means the first infliximab product to be considered for reimbursement for infliximab-naïve patients.

All Special Authorization requests for coverage of infliximab for infliximab-naïve patients requiring the drug for the above indications will be assessed for the Inflectra brand of infliximab only. Patients whose initial Special Authority was received before June 1, 2016 will be eligible for coverage of Remicade. 

Patients will not be permitted to switch from Inflectra to another infliximab product or vice versa, if previously trialed and deemed unresponsive to therapy. 

Coverage of the Remicade brand of infliximab will continue for patients previously approved for NLPDP coverage of Remicade; they will also be eligible for coverage of the Inflectra brand should they choose to switch. 

ACE is interested in hearing from patients about their experience with biosimilars in Newfoundland and Labrador. Do you have biosimilar news to share?

Nova Scotia

Effective June 1, 2016, under the Exception Status Drug program, infliximab (Inflectra) is authorized for the treatment of ankylosing spondylitis, plaque psoriasis, or rheumatoid arthritis.

For infliximab-naïve patients whose infliximab therapy is initiated after June 1, 2016, infliximab (Inflectra) will be the product approved for rheumatoid arthritis and ankylosing spondylitis.

ACE is interested in hearing from Nova Scotia patients about their experience with biosimilars. Do you have biosimilar news to share?

Prince Edward Island

Effective June 27, 2016, under the High Cost Drug Program and Catastrophic Drug Program, infliximab (Inflectra) will be the product approved for ankylosing spondylitis, plaque psoriasis, psoriatic arthritis, and rheumatoid arthritis.

For infliximab-naïve patients effective June 27, 2016 or later, infliximab (Inflectra) will be the product approved for the ankylosing spondylitis, plaque psoriasis, psoriatic arthritis or rheumatoid arthritis. Naïve patients are defined as those not on maintenance infliximab therapy (including those receiving induction therapy) as of the effective date of coverage on PEI (June 27, 2016).

ACE is interested in hearing from patients about their experience with biosimilars in PEI. Do you have biosimilar news to share?